UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004250
Receipt No. R000005104
Scientific Title Multicenter Study of Efficacy and Safety of recombinant thrombomodulin alfa for Obstetric disseminated intravascular coagulation (DIC)
Date of disclosure of the study information 2010/09/27
Last modified on 2013/03/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Multicenter Study of Efficacy and Safety of recombinant thrombomodulin alfa for Obstetric disseminated intravascular coagulation (DIC)
Acronym Multicenter Study of Efficacy and Safety of rTM for Obstetric DIC
Scientific Title Multicenter Study of Efficacy and Safety of recombinant thrombomodulin alfa for Obstetric disseminated intravascular coagulation (DIC)
Scientific Title:Acronym Multicenter Study of Efficacy and Safety of rTM for Obstetric DIC
Region
Japan

Condition
Condition Disseminated intravascular coagulation (DIC)
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety of rTM in patients with obstetric DIC.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Course of obstetric DIC score
Key secondary outcomes Course of DIC score; Course of clinical symptom; Course of blood clotting test findings; Outcome of subjects; Transfusion; Blood loss; Adverse events; Adverse drug reaction

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1.Patients diagnosed clinically as DIC (the obstetrical DIC score reaches 8 points or more).
2.Postpartum or intrauterine fetal resuscitation.
3.Written informed consent of participation.
Key exclusion criteria 1.Patients showing intracranial, pulmonary or gastrointestinal hemorrhage.
2.Patients with a history of hypersensitivity to rTM.
3.Pregnant women, nursing mothers or possibly pregnant women (Fetal viability).
4.Hematopoetic malignancy.
5.Other patients judged to be inappropriate at the discretion of investigators.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masao Nakabayashi
Organization Maternal and Child Health Center Aiiku Hospital
Division name Department of Obstetrics and Gynecology
Zip code
Address 5-6-8 Minami-Azabu, Minato-Ku, Tokyo 106-8580, Japan
TEL 03-3473-8321
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Maternal and Child Health Center Aiiku Hospital
Division name Department of Obstetrics and Gynecology
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Maternal and Child Health Center Aiiku Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 順天堂大学医学部附属順天堂医院(東京都)
埼玉医科大学総合医療センター(埼玉県)
県西部浜松医療センター(静岡県)
宮崎大学医学部附属病院(宮崎県)

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 27 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2010 Year 09 Month 16 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
2013 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective observational study

Management information
Registered date
2010 Year 09 Month 22 Day
Last modified on
2013 Year 03 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005104

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.